APPLICATION
ANDA086283
TYPE
ANDA
ORIGINAL APPROVAL
1979-08-07
LATEST ACTION
2025-08-22
ROUTE
TOPICAL
DOSAGE FORM
JELLY
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 2% · JELLY · TOPICAL
Approval history
2025-08-22Labeling · Supplement 29 · standardAP
2025-08-22Labeling · Supplement 30 · standardAP
1995-09-19Manufacturing (CMC) · Supplement 16AP
1994-06-17Manufacturing (CMC) · Supplement 15AP
1993-08-25Labeling · Supplement 14AP
1993-02-08Manufacturing (CMC) · Supplement 11AP
1992-12-17Manufacturing (CMC) · Supplement 13AP
1987-07-10Manufacturing (CMC) · Supplement 7AP
1987-03-05Manufacturing (CMC) · Supplement 5AP
1986-05-16Manufacturing (CMC) · Supplement 2AP
1986-05-16Manufacturing (CMC) · Supplement 3AP
1979-08-07OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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